Advance authorisation for non infringing pharmaceutical manufacturing requires detailed input accounting and Central Excise certification of consumed inputs. Advance authorisation for pharmaceutical products manufactured through a Non Infringing (NI) process requires maintaining Appendix 4I register recording authorisation details, inputs (names and quantities), exported product and quantities, inputs actually consumed, balanced inputs and proportional reductions where partial or nil imports occurred; post export replenishment and documentary evidence must be furnished. A Central Excise Certificate, signed by an official not below Superintendent, must verify production records and state per unit input consumption. A solvent allowance policy ties permissible solvent quantities to ANDA/DMF requirements, subject to Central Excise verification.